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Ampyra for Optic Neuritis in MS

This study has been completed.
Acorda Therapeutics
Information provided by (Responsible Party):
Robert Naismith, Washington University School of Medicine Identifier:
First received: April 13, 2011
Last updated: February 14, 2014
Last verified: February 2014
Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery after optic neuritis from MS, will result in symptomatic improvement in visual function. The study will consist of one screening/baseline visit, one visit during treatment with active drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned to receive study medication or placebo for the first three weeks, followed by a two week wash-out, and then treatment reallocation for the latter three weeks.

Condition Intervention Phase
Multiple Sclerosis
Optic Neuritis
Drug: Dalfampridine/Placebo
Drug: Placebo/Dalfampridine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Efficacy of Dalfampridine on visual function (contrast sensitivity). [ Time Frame: 8 weeks ]
    Dalfampridine treatment will improve visual function, measured by the 5% ETDRS contrast sensitivity chart, in subjects with long-term visual impairment secondary to optic neuritis from MS.

Secondary Outcome Measures:
  • Dalfampridine reduce visual evoked potential P100 latency. [ Time Frame: 8 weeks ]
    Dalfampridine treatment will reduce visual evoked potential P100 latency following remote optic neuritis.

  • Dalfampridine improvement in other vision testing (acuity, color, and fields). [ Time Frame: 8 weeks ]
    Dalfampridine treatment will result in an improvement in visual fields, high contrast visual acuity, and color vision.

  • Dalfampridine affect on quality of life. [ Time Frame: 8 weeks ]
    Dalfampridine treatment will result in an improvement quality of life.

Enrollment: 53
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A: Dalfampridine/Placebo Drug: Dalfampridine/Placebo
Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
Other Names:
  • Ampyra (R)
  • Fampridine
Active Comparator: Group B: Placebo/Dalfampridine Drug: Placebo/Dalfampridine
Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
Other Names:
  • Ampyra (R)
  • Fampridine

  Show Detailed Description


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria are:

  1. At least one previous clinical episode of optic neuritis,
  2. the last episode of ON must have occurred at least 12 months prior to study entry,
  3. clinically definite MS, defined by the revised McDonald criteria, 23
  4. ages 18-70,
  5. visual acuity greater than or equal to 20/30
  6. must be able to read at least 2 of the 5 letters on the top line of the 5% ETDRS chart (logMAR 0.96) at 3 meters, 2 meters or 1 meter, and
  7. must have sufficient cognitive function to understand the consent process and to reliably perform all clinical assessments

Exclusion criteria are:

  1. Any ophthalmologic condition, other than ON, which can affect vision, including nystagmus in primary position of gaze,
  2. history of seizures or spells with altered level of consciousness,
  3. pregnancy or breast feeding,
  4. an MS exacerbation or use of glucocorticoids within 3 months of entry,
  5. a history of moderate to severe renal insufficiency,
  6. previous use of 4-aminopyridine, in any formulation, in the prior 4 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01337986

United States, Missouri
Washington University (John L. Trotter MS Center)
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Acorda Therapeutics
Principal Investigator: Robert T Naismith, MD Washington University School of Medicine
  More Information

Farnsworth D. The Farnsworth-Munsell 100-hue and dichotomous tests for color vision. J Opt Soc Am 1943;33:568-574.
Acorda Therapeutics. AMPRYA package insert (2010).

Responsible Party: Robert Naismith, Assistant Professor of Neurology, Washington University School of Medicine Identifier: NCT01337986     History of Changes
Other Study ID Numbers: Ampyra Vision 2011 RTN
WU HRPO# : 201104126 ( Other Identifier: Washington University HRPO )
Study First Received: April 13, 2011
Last Updated: February 14, 2014

Keywords provided by Washington University School of Medicine:
Multiple Sclerosis
Optic Neuritis
Remote Optic Neuritis
Contrast Sensitivity

Additional relevant MeSH terms:
Optic Neuritis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017